EUCTR2015-000640-42-IT进行中（未招募）1 期
A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib incombination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 135 人开始时间: 2018年2月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Written informed consent consistent with ICH-GCP and local laws,
- •signed prior to any study procedures being performed (including any
- •required washout)
- •-Male or female patients aged greater than or equal to 40 years at visit 1
- •-Idiopathic Pulmonary Fibrosis (IPF) diagnosis, based upon the
- •ATS/ERS/JRS/ALAT 2011 guideline and confirmed by the investigator
- •based on chest high resolution computed tomography (HRCT) scan
- •performed within 12 months of visit 1
- •-FVC greater than or equal to 50% of predicted normal at visit 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-ALT, AST > 1.5 fold upper limit of normal (ULN) at visit 1
- •-Total bilirubin > 1.5 fold ULN at visit 1
- •-Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7)
- •-History of myocardial infarction within 6 months of visit 1 or unstable
- •angina within 1 month of visit 1
- •-Bleeding Risk: Known genetic predisposition to bleeding, Patients who
- •require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
- •antagonists, dabigatran, heparin, hirudin etc) or high dose antiplatelet
- •therapy, History of haemorrhagic central nervous system event within 12
- •months prior to visit 1, History of haemoptysis or haematuria, active
- •gastro-intestinal bleeding or ulcers and/or major injury or surgery
- •within 3 months prior to visit 1, International normalised ratio (INR) > 2
- •at visit 1, Prothrombin time and partial thromboplastin time (PTT) >
- •institutional ULN at visit 1
- •-Planned major surgery during the trial participation, including lung
- •transplantation,major abdominal or major intestinal surgery.
- •-History of thrombotic event (including stroke and transient ischemic
- •attack) within 12
- •months of visit 1
- •-Severe renal impairment (Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula) or end-stage renal disease requiring dialisys.
- •-Treatment with NAC, prednisone >15 mg daily or >30 mg every 2 days
- •OR equivalent
- •dose of other oral corticosteroids and/or fluvoxamine within 2 weeks of
- •-Treatment with azathioprine, cyclophosphamide, cyclosporine as well as
- •investigational drug within 8 weeks of visit 2
- •-Previous treatment with pirfenidone
- •-Permanent discontinuation of nintedanib in the past due to AEs
- •considered drug-related
- •-Known hypersensitivity to nintedanib, pirfenidone, peanut or soya or to
- •-A disease or condition which in the opinion of the investigator may
- •interfere with testing procedures or put the patient at risk when
- •participating in this trial
- •-Alcohol or drug abuse which in the opinion of the treating physician
- •would interfere with treatment
- •-Women who are pregnant, nursing, or who plan to become pregnant
- •while in the trial.
- •-Women of childbearing potential not willing or able to use highly
- •effective methods of
- •birth control per ICH M3 (R2) that result in a low failure rate of less than
- •1% per year
- •when used consistently and correctly5 for 28 days prior to and 3 months
- •after nintedanib administration
- •-Patients not able to understand and follow study procedures including
- •completion of selfadministered questionnaires without help
- •-Patients who require dose reduction and/or temporary interruption
- •during the run-in period with nintedanib 150 mg bid
研究者
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